Moderna Wins COVID-19 Patent Dispute Against Pfizer, BioNTech

The European Patent Office (EPO) has ruled in favor of Moderna in its ongoing patent dispute with Pfizer and BioNTech over their COVID-19 vaccine. According to The Financial Times, the decision was made in an oral ruling maintaining the validity of Moderna’s patent ‘949, which pertains to specific modifications to mRNA molecules intended to reduce immunogenicity, avoid the immune system, and enhance translation in the body. These modifications also outline the potential applications of the altered mRNA.

Pfizer and BioNTech now have a two-month window to appeal this decision, with Pfizer indicating to The Financial Times that it may consider an appeal. BioNTech also responded to the ruling, stating its intention to continue defending its innovations against all patent infringement claims, including the current case.

The legal conflict began in August 2022, when Moderna initiated a lawsuit against Pfizer and BioNTech. Moderna alleged that the companies had violated its protected mRNA technology to develop their COVID-19 vaccine, Comirnaty. The lawsuit centered on two aspects of Comirnaty: the method of encoding the spike protein within a lipid nanoparticle and the specific mRNA modification, which Moderna claims is identical to that used in its own vaccine, Spikevax.

In an attempt to counter Moderna’s claims, Pfizer and BioNTech petitioned the U.S. Patent Trademark Office (PTO) in August 2023, requesting an inter partes review of Moderna’s patents in order to invalidate them. The companies argued that Moderna’s patents were overly broad and attempted to claim pre-2015 knowledge as their own, which is before the priority date of Moderna’s patents.

Recently, the U.S. District Court for the District of Massachusetts provided Pfizer and BioNTech a temporary pause in the legal proceedings. The court granted the companies’ request for a stay pending the results of the PTO’s review. Judge Richard Stearns noted that waiting for the PTO’s decision could potentially simplify the issues in the case.

Moderna’s recent patent victory comes at a time when the company is facing significant declines in COVID-19 related revenues. In its first-quarter 2024 earnings report, Moderna recorded total revenue of $167 million, a steep drop from the $1.9 billion reported in the same quarter of the previous year. This decline is attributed to decreased sales of its COVID-19 vaccine. Net product sales for the quarter were $167 million, representing a 91% decrease compared to the same period last year.

Pfizer is experiencing similar financial challenges, having reported a notable decrease in COVID-19 related revenues. Earlier this month, the company disclosed a 20% year-over-year drop in its Q1 2024 financial report. In 2023, Pfizer's revenues saw a 42% decline.

The ongoing patent dispute and revenue declines highlight the competitive and financial pressures facing major pharmaceutical companies in the aftermath of peak COVID-19 vaccine sales. The outcome of the appeal and the PTO’s review will likely have significant implications for all parties involved. 

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!